Catalog Number

-

Brand Name

SURFLO

Version/Model Number

SR-OX2419CA

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K133280,K133280,K133280,K133280

Product Code

FOZ

Product Code Name

Catheter,intravascular,therapeutic,short-term less than 30 days

Public Device Record Key

3dc01848-098c-405c-b9ac-c809300c3528

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 14, 2016

Package DI Number

54806017512281

Quantity per Package

4

Contains DI Package

34806017512287

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Carton